Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-02-22 @ 4:34 AM
Study NCT ID:
NCT04987359
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-04
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2021-07-13', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cardiorespiratory fitness capacity (co-primary)', 'timeFrame': 'Baseline, Week 10', 'description': 'Cardiorespiratory fitness (VO2peak) assessed by a symptom-limited cardiopulmonary exercise test.'}, {'measure': 'Change in body weight (co-primary)', 'timeFrame': 'Baseline, Week 10', 'description': 'Bodyweight assessed using a digital scale in a fasting state with an empty bladder, without shoes, and only wearing light clothing.'}], 'secondaryOutcomes': [{'measure': 'Change in waist Circumference', 'timeFrame': 'Baseline, Week 10', 'description': 'Measured midway between the lower rib margin and the iliac crest.'}, {'measure': 'Change in fat Mass', 'timeFrame': 'Baseline, Week 10', 'description': 'Measured by dual-energy x-ray absorptiometry'}, {'measure': 'Change in systolic blood pressure', 'timeFrame': 'Baseline, Week 10', 'description': 'Seating, resting for 5 minutes before the measure is taken'}, {'measure': 'Change in diastolic blood pressure', 'timeFrame': 'Baseline, Week 10', 'description': 'Seating, resting for 5 minutes before the measure is taken'}, {'measure': 'Change in medication use', 'timeFrame': 'Baseline, Week 10', 'description': 'Medications related to cholesterol, diabetes, and blood pressure'}, {'measure': 'Change in physical and mental quality-of-life', 'timeFrame': 'Baseline, Week 10', 'description': 'Assessed using the 36-Item Short Form Survey (SF-36)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasm Malignant']}, 'referencesModule': {'references': [{'pmid': '41114371', 'type': 'DERIVED', 'citation': 'Brown JC, Nauta P, Whitehead D, Dubin BR, Nash R, Blumberg K, Green T, Brown J, Compton SLE, Miletello GP. A randomized trial of a multimodal lifestyle intervention in cancer survivors. Front Oncol. 2025 Oct 2;15:1682244. doi: 10.3389/fonc.2025.1682244. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'To examine the efficacy of a 10-week multimodal lifestyle program, versus waitlist control, on cardiorespiratory fitness capacity and body weight in survivors of cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability to provide informed consent before any trial-related activities\n* History of any malignancy\n* Completion of cancer-directed therapy (e.g., surgery, chemotherapy, and radiotherapy) prior to enrollment (patients receiving ongoing endocrine or targeted therapy are eligible to participate)\n* No evidence of residual or recurrent cancer under active treatment\n* Age ≥18 years\n* Body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 with one or more treated or untreated weight-related coexisting conditions\n* Willing to be randomized\n* Allow the collection and storage of biospecimens and data for future use\n\nExclusion Criteria:\n\n* Engaging in ≥3 purposeful exercise sessions per week, on average, over the past 12 weeks\n* Significant purposeful weight loss (\\>11 kg) within the past 12 weeks\n* Current use of medications or devices for the purpose of weight loss\n* Metabolic or bariatric surgery within the last year\n* Cardiovascular, respiratory, or musculoskeletal disease that would prohibit participation in an exercise and weight loss program\n* Currently pregnant, breastfeeding, or planning to become pregnant with the next 12 weeks\n* Psychiatric disorders or conditions that would preclude participation in the study intervention\n* Any other condition which, in the opinion of the investigator, may impede testing of the study hypothesis or make it unsafe to engage in the study'}, 'identificationModule': {'nctId': 'NCT04987359', 'acronym': 'Small Steps', 'briefTitle': 'A Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'A Randomized Trial of a Multimodal Lifestyle Intervention to Optimize Survivorship After Cancer', 'orgStudyIdInfo': {'id': 'PBRC 2021-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multimodal Lifestyle Program', 'description': 'The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling. The main objective of the structured exercise training is to improve cardiorespiratory fitness.', 'interventionNames': ['Behavioral: Multimodal Lifestyle Program']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control', 'description': 'The waitlist control group will be asked to maintain their current exercise and dietary habits for the 10-week study period. Upon providing study endpoint data at week 10, control group participants will be offered a 4-week multimodal lifestyle program that is similar to the intervention group.'}], 'interventions': [{'name': 'Multimodal Lifestyle Program', 'type': 'BEHAVIORAL', 'description': 'The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling.', 'armGroupLabels': ['Multimodal Lifestyle Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Justin C Brown, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Justin Brown', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}